Youth Soccer Header Study
Primary Purpose
Brain Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Header Session
MRI Session
Sponsored by
About this trial
This is an interventional basic science trial for Brain Injuries focused on measuring soccer, concussion, sports injuries
Eligibility Criteria
Inclusion Criteria:
- Age 12-13 or 16-18 years
- Currently participating in organized interscholastic or club soccer
- No active musculoskeletal injury that limits full participation in soccer activities
Exclusion Criteria:
- 14-15 year old are not eligible
- History of prior concussion or other head injury
- History of prior cervical spine injury
- Potential participants who can not participate in the MRI scan will be excluded
- Pregnancy or possible pregnancy (one reason for MRI exclusion)
Sites / Locations
- University of Wisconsin School of Medicine and Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Older Adolescent Soccer Players
Younger Adolescent Soccer Players
Arm Description
10 male, 10 female soccer players, grades 11-12, age 16-18 Neurocognitive measures, physical measures, header session, MRI
10 male, 10 female soccer players, grades 6-7, age 12-13 Neurocognitive measures, physical measures, header session, MRI
Outcomes
Primary Outcome Measures
Force Strain Kinematic Model Development: Maximum Strain
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Force Strain Kinematic Model Development: Minimum Principle Strain
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Force Strain Kinematic Model Development: Maximum Axonal Strain
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Whole brain tractography (fiber tracking) created by MRI scans
Whole brain tractographs will be created from MRI scans using Diffusion Tensor Imaging.
Brain Injury Probability Map Development: Change in Tissue Strain
The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk.
Secondary Outcome Measures
BRIEF-Monitoring Trail Making Parts A and B Score
The Trail Making Test is administered in two parts. Part A is a visual-scanning, timed task where subjects are asked to connect with lines 25 circles numbered from 1 to 25 as quickly as possible. In Part B participants are asked to connect circles containing numbers (from 1 to 13) or letters (from A to L) in an alternate numeric/alphabetical order (i.e. 1-A-2-B-3-C etc.). Errors must be corrected immediately and the sequence re-established. The TMT A-B score, calculated as the difference between TMT-A and TMT-B times, is considered a measure of cognitive flexibility relatively independent of manual dexterity.
Sport Concussion Assessment Tool 5 (SCAT5) Symptom Severity Score
The SCAT5 contains a 22 item concussion symptom evaluation scale with score of 0-6 for each symptom and total score 0-132, higher scores indicate more severe symptoms.
Sport Concussion Assessment Tool 5 (SCAT5) Number of Symptoms
The SCAT5 contains a 22 item concussion symptom evaluation scale with score of 0-6 for each symptom and total score 0-132, higher scores indicate more severe symptoms.
Patient Health Questionnaire (PHQ-9) Score
The PHQ-9 has 9 items with 0-3 scale for 0-27 total score. Higher score indicates greater level of depression. Scores of 0-4, 5-9, 10-14, 15-19 and >20 correspond to minimal or none, mild, moderate, moderately severe symptoms.
General Anxiety Disorder Scale-7 (GAD-7) Score
The GAD-7 has 7 items with 0-3 scale for 0-21 total score. Higher score indicates greater level of anxiety. Scores of 0-4, 5-9, 10-14, and 15-21 correspond to minimal or none, mild, moderate, and severe symptoms.
Pediatric Quality of Life Inventory (PEDS-QL) Score
The PedsQL is a generic measure of Health-related Quality of Life. The PedsQL consists of 23 questions that measure the domains of emotional, physical, social, and school function to calculate a physical and psychosocial summary as well as total score. The total score (23 items) is a summary score of all subscale scores (total range of scores from 0-92, higher scores indicate poorer quality of life), and the psychosocial functioning score (15 items) is a summary score of the emotional-functioning (5 items), social-functioning (5 items), and school-functioning (5 items) subscale scores (total range of scores from 0-60 where higher scores indicate poorer quality of life).
Deep Cervical Flexor Endurance Test (DCFET)
The subject lies supine flat on their back, tuck their chin toward their chest and lift their head and neck approximately 2.5 cm off the ground and hold that position as long as possible. The length of time is recorded in seconds, and typically is 45-60 sec.
Y Balance Test (YBT)
Leg length is measured (cm). The test consists of a centralized stance platform and three pipes connected with the platform. The pipes represent AT (Anterior), PM (Posterior Medial), and PL (Posterior Lateral) reach directions and are marked in 1.0-cm increments for measurement purposes. All pipes are equipped with a moveable reach indicator. During the testing procedure, subjects stand with one leg on the centralized platform and are instructed to reach with the other leg as far as possible in the AT, PM, and PL directions while maintaining balance. Each subject will perform three practice trials followed by three data collection trials per leg. Starting with the AT reach direction while standing on the right leg followed by standing on the left leg, this protocol is then replicated for the PM and PL directions.
Full Information
NCT ID
NCT04919707
First Posted
May 25, 2021
Last Updated
January 3, 2022
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04919707
Brief Title
Youth Soccer Header Study
Official Title
Evaluation of Head Kinematics, Force-strain Models, and Correlation of MRI Markers With Neurocognitive Testing in Youth Soccer Heading
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks. 40 youth soccer players will be recruited from the Madison, WI area and can expect to be on study for 2 months.
Detailed Description
Despite the large popularity of soccer worldwide and in the US, the majority of research on sport-related head impacts has been concentrated in male American football players using head-impact measurement sensors in instrumented football helmets. The limited research in soccer players likewise has focused on males, particularly those playing at an elite level, such as collegiate or professional. Unfortunately there is a paucity of data on youth soccer athletes in regards to how these younger players actually head the ball and what forces they experience. Measurement of head impacts is essential to further understanding the potential risks associated with heading in youth soccer, and to further inform rule or policy changes that limit head impact exposure in these younger age groups.
Specific Aim: Establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks.
In this study, age-and sex-specific force strain models will be validated using a study of soccer headers under controlled conditions. Youth soccer players in 6th-12th grade will be recruited to participate in a header training session while wearing motion sensor headbands. All children will undergo MRI scanning and baseline assessment of neurocognitive function, psychological health, and academic aptitude and performance. Participant-specific finite element models will be created from MRI scans, and principle tissue strains will be determined based on head motion profiles during soccer headers and compared between age- and sex-specific groups.
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. MRI scans will be obtained in all participants, and individualized and population averaged (to reduce computational burden), whole brain tractographs will be created. New participants-specific finite element models will be generated using geometry-adaptive mesh morphing techniques to match the head morphology of each subject using a baseline FE head model (to reduce model development time). The linear and angular acceleration histories obtained from the pre- and post-training soccer heading tasks will be applied directly to the FE models to simulate the head motion of each participant. The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session. This analysis will provide insight into the effect of age and training on improving heading techniques and reducing the risk of injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
soccer, concussion, sports injuries
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Older Adolescent Soccer Players
Arm Type
Experimental
Arm Description
10 male, 10 female soccer players, grades 11-12, age 16-18 Neurocognitive measures, physical measures, header session, MRI
Arm Title
Younger Adolescent Soccer Players
Arm Type
Experimental
Arm Description
10 male, 10 female soccer players, grades 6-7, age 12-13 Neurocognitive measures, physical measures, header session, MRI
Intervention Type
Behavioral
Intervention Name(s)
Header Session
Intervention Description
Participant fit with commercially available Storelli ExoShield Head Guard that has been fit with head impact sensors; participant completes a set of basic standing header tasks which mimic the types of purposeful heading anticipated to occur in actual play in soccer practice and games.
Intervention Type
Procedure
Intervention Name(s)
MRI Session
Intervention Description
Scanning will include high resolution T1w imaging for 3-dimensional structural analyses, DTI and resting-state MRI for assessment of structural and functional brain network connectivity, as well as susceptibility-weighted imaging and multicomponent relaxometry to assess for microhemorrhages and myelin damage.
Primary Outcome Measure Information:
Title
Force Strain Kinematic Model Development: Maximum Strain
Description
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Time Frame
up to 2 months
Title
Force Strain Kinematic Model Development: Minimum Principle Strain
Description
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Time Frame
up to 2 months
Title
Force Strain Kinematic Model Development: Maximum Axonal Strain
Description
High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.
Time Frame
up to 2 months
Title
Whole brain tractography (fiber tracking) created by MRI scans
Description
Whole brain tractographs will be created from MRI scans using Diffusion Tensor Imaging.
Time Frame
up to 2 months
Title
Brain Injury Probability Map Development: Change in Tissue Strain
Description
The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk.
Time Frame
During the header task session, up to 2 months
Secondary Outcome Measure Information:
Title
BRIEF-Monitoring Trail Making Parts A and B Score
Description
The Trail Making Test is administered in two parts. Part A is a visual-scanning, timed task where subjects are asked to connect with lines 25 circles numbered from 1 to 25 as quickly as possible. In Part B participants are asked to connect circles containing numbers (from 1 to 13) or letters (from A to L) in an alternate numeric/alphabetical order (i.e. 1-A-2-B-3-C etc.). Errors must be corrected immediately and the sequence re-established. The TMT A-B score, calculated as the difference between TMT-A and TMT-B times, is considered a measure of cognitive flexibility relatively independent of manual dexterity.
Time Frame
up to 2 months
Title
Sport Concussion Assessment Tool 5 (SCAT5) Symptom Severity Score
Description
The SCAT5 contains a 22 item concussion symptom evaluation scale with score of 0-6 for each symptom and total score 0-132, higher scores indicate more severe symptoms.
Time Frame
up to 2 months
Title
Sport Concussion Assessment Tool 5 (SCAT5) Number of Symptoms
Description
The SCAT5 contains a 22 item concussion symptom evaluation scale with score of 0-6 for each symptom and total score 0-132, higher scores indicate more severe symptoms.
Time Frame
up to 2 months
Title
Patient Health Questionnaire (PHQ-9) Score
Description
The PHQ-9 has 9 items with 0-3 scale for 0-27 total score. Higher score indicates greater level of depression. Scores of 0-4, 5-9, 10-14, 15-19 and >20 correspond to minimal or none, mild, moderate, moderately severe symptoms.
Time Frame
up to 2 months
Title
General Anxiety Disorder Scale-7 (GAD-7) Score
Description
The GAD-7 has 7 items with 0-3 scale for 0-21 total score. Higher score indicates greater level of anxiety. Scores of 0-4, 5-9, 10-14, and 15-21 correspond to minimal or none, mild, moderate, and severe symptoms.
Time Frame
up to 2 months
Title
Pediatric Quality of Life Inventory (PEDS-QL) Score
Description
The PedsQL is a generic measure of Health-related Quality of Life. The PedsQL consists of 23 questions that measure the domains of emotional, physical, social, and school function to calculate a physical and psychosocial summary as well as total score. The total score (23 items) is a summary score of all subscale scores (total range of scores from 0-92, higher scores indicate poorer quality of life), and the psychosocial functioning score (15 items) is a summary score of the emotional-functioning (5 items), social-functioning (5 items), and school-functioning (5 items) subscale scores (total range of scores from 0-60 where higher scores indicate poorer quality of life).
Time Frame
up to 2 months
Title
Deep Cervical Flexor Endurance Test (DCFET)
Description
The subject lies supine flat on their back, tuck their chin toward their chest and lift their head and neck approximately 2.5 cm off the ground and hold that position as long as possible. The length of time is recorded in seconds, and typically is 45-60 sec.
Time Frame
up to 2 months
Title
Y Balance Test (YBT)
Description
Leg length is measured (cm). The test consists of a centralized stance platform and three pipes connected with the platform. The pipes represent AT (Anterior), PM (Posterior Medial), and PL (Posterior Lateral) reach directions and are marked in 1.0-cm increments for measurement purposes. All pipes are equipped with a moveable reach indicator. During the testing procedure, subjects stand with one leg on the centralized platform and are instructed to reach with the other leg as far as possible in the AT, PM, and PL directions while maintaining balance. Each subject will perform three practice trials followed by three data collection trials per leg. Starting with the AT reach direction while standing on the right leg followed by standing on the left leg, this protocol is then replicated for the PM and PL directions.
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 12-13 or 16-18 years
Currently participating in organized interscholastic or club soccer
No active musculoskeletal injury that limits full participation in soccer activities
Exclusion Criteria:
14-15 year old are not eligible
History of prior concussion or other head injury
History of prior cervical spine injury
Potential participants who can not participate in the MRI scan will be excluded
Pregnancy or possible pregnancy (one reason for MRI exclusion)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Alison Brooks, MD, MPH
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Youth Soccer Header Study
We'll reach out to this number within 24 hrs